Teeth LossNCT06382337
Immediate Dental Implants in The Upper Anterior Region
A study testing Group A : ice cream cone technique and Group B : the vestibular socket therapy in people with Teeth Loss and Alveolar Bone Resorption, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of the study will be to evaluate maxillary anterior teeth replacement with immediate dental implant utilizing vestibular socket therapy versus ice cream cone technique both clinically and radiographically. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Teeth Loss, Alveolar Bone Resorption
- What is being tested?
- Group A : ice cream cone technique and Group B : the vestibular socket therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Apr 2024to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age more than 18 - 40 years.
- Patients with missing single tooth or teeth in the esthetic zone.
- Patients with buccal wall defect Type 2 A, B sockets (thin labial plate of bone less than 0.5 mm, presence of dehiscence or fenestration).
- Good oral hygiene.
- Patients willing to be present during the study follow-up intervals.
- Patients free from any systemic diseases that may contraindicate implant placement .
- Crown height space of at least 8 mm.
- Patients without any para-functional habits (bruxism and clenching).
Who cannot join
- Smoking people.
- Alcohol or drug abuse.
- Pregnancy.
- Patients with poor oral hygiene or progressive periodontal disease .
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry Mansoura University
Al Mansurah, 7650001
050 2248512, dentfac@mans.edu.eg
Mohamed Fa Shoeib, demonstrator
About this study
Official title: Maxillary Anterior Teeth Replacement With Immediate Dental Implants Utilizing Vestibular Socket Therapy Versus Ice Cream Cone Technique
The aim of the study will be to evaluate maxillary anterior teeth replacement with immediate dental implant utilizing vestibular socket therapy versus ice cream cone technique both clinically and radiographically.
Read the detailed description
Tooth loss is the endpoint of oral diseases, such as dental caries and periodontitis, and reflects the utilization of dental services during a lifetime .
The incidence of tooth loss has significantly declined at the global levels. However, tooth loss and oral diseases are still a major public health concern worldwide.
In the anterior region, the common reason for tooth loss is due to traumatic injury or congenital anomaly, loss of a single tooth may cause functional and esthetic deficits to the patient. Tooth extraction usually accompanies alveolar ridge resorption along with loss of preexisting tissue morphology.
There is a new developed a post-extraction fresh socket classification system as follows: Type 1: The facial soft tissue and buccal plate of bone are at normal levels in relation to the cement enamel junction of the pre-extracted tooth and remain intact post extraction.
Type 2: Facial soft tissue is present, but the buccal plate is partially missing following extraction of the tooth. Type 3: The facial soft tissue and the buccal plate of the bone are both markedly reduced after tooth extraction. This classification enabled ordering and classifying of post-extraction sockets.
A recently published sub-classification of type 2, now allows even greater clarity to plan regeneration: Type 2 A: Absence of the coronal one-third of labial bone plate of the extraction socket 5mm to 6mm from the free gingival margin. Type 2 B: Absence of the middle to coronal two thirds of the labial bone plate of the extraction socket approximately 7mm to 9mm from the free gingival margin.
Type 2 C: Absence of the apical one-third of the labial bone plate of the extraction socket 10 mm or more from the free gingival margin. For the management of socket defects after extraction numerous techniques have been developed to allow for optimum esthetic and functional outcomes. Among those techniques are ice cream cone technique described by Deniss Tarnow and the more recently introduce vestibular socket therapy (VST) introduced by Abd Salam Elaskary . Deniss Tarnow invented his technique (ice cream cone) to augment the socket with buccal dehiscence, in this technique, socket preservation was done using a collagen membrane shaped into an ice cream cone and placing it inside the extraction socket to cover the dehiscence site and the socket occlusally at the same time.
The regeneration of the buccal plate using the "ice cream cone" technique was possible in the dental extraction and by the immediate implant in an infected site in a case report of a 53 years old patient, and also in a clinical case series. But this technique is only recommended for simple dehiscence and not a wall defect. This technique is not applicable for a completely defective or missing bone wall unless a flap is raised, and (GBR) procedure is performed. Difficulty in placing the membrane as it become softened when exposed to fluid. In 2020 , Abd salam Elaskary , introduced vestibular socket therapy (VST), a novel minimally invasive surgical technique that allowed placement of immediate implant in maxillary class I and class II fresh extraction sockets with or without infective signs.
A 1-cm long vestibular access incision was made using a 15 blade 5-6 mm apical to the mucogingival junction of the socket, exposing the alveolar bone. The vestibular tissues were dissected in a coronal direction to detach the periosteum, forming a sub-periosteal tunnel connecting the vestibular incision to the socket orifice,bone graft was then introduced through the vestibular access incision to augment the labial plate of bone and fill any jumping gap. A flexible cortical membrane of 0.6 mm thickness was inserted and positioned 1 mm apical to the soft tissue margin and secured using two tacks apically. A customized healing abutment was fabricated to cover the implant and seal the socket .
This technique has many advantages : firstly, the nature of the vestibular extraction approach does not cause any trauma, pressure, or laceration to the soft tissue margin, which in turn has a positive impact on enhancing the mid-facial soft tissue levels, as the root was only pushed in an incisal direction through the created 6vestibular pouch, thus minimizing the osteoclastic activity around the socket rim .
, so it overcomes the remodeling sequelae of tooth extraction and to minimize the mid facial peri-implant gingival recession.
Secondly ,the use of a slowly resorbing flexible labial shield allowed for remodeling of the underlying labial bone plate while maintaining the socket dimensions and contours throughout the follow-up period. Thirdly, the membrane fixation, which is known to be pivotal for the GBR stability and regenerative outcomes. and finally connective tissue grafting can be done in type II sockets exhibiting a thin biotype. In these cases, the soft tissue graft counteracted the detrimental effect of the thin gingival phenotype on horizontal bone loss and midfacial mucosal recession.
VST can manage both type I and II socket defects, and could shorten the treatment time by up to two-thirds of that required for bone grafting and delayed implant placement.
- Conditions
- Teeth Loss, Alveolar Bone Resorption
- Being tested
- Group A : ice cream cone technique, Group B : the vestibular socket therapy
- Keywords
- VST, immediate dental implants, ice cream cone technique, Type 2 socket
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A : ice cream cone techniqueOther
collagen membrane and allograft bone for labial plate augmentation simultaneously with immediate implants placements in maxillary anterior region in the defected type 2 socket , custom healing abutment for soft tissue preservation in ice cream cone group
Group B : the vestibular socket therapyOther
cortical lamina fixed by bone tacks and allograft bone for labial plate augmentation simultaneously with immediate implants placements in maxillary anterior region in the defected type 2 socket , custom healing abutment for soft tissue preservation in ice cream cone group
| Study group | Role | What they receive |
|---|---|---|
| Group A :immediate dental Implants cases with ice-cream cone technique in type 2 socket | Experimental | immediately placed implants in which the socket defect will be treated utilizing ice cream cone technique by Dennis Tarnow using collagen membrane , allograft bone graft and custom healing abutments Receives: Other: Group A : ice cream cone technique |
| Group B : immediate dental Implants cases with the vestibular socket therapy in type 2 socket | Experimental | 8 immediately placed implants in which the socket defect will be treated utilizing vestibular socket therapy technique using cortical lamina , allograft , bone tacks for fixation and custom healing abutment Receives: Other: Group B : the vestibular socket therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone changes
bone changes in volume by cone-beam computed tomography (CBCT )radiographically .
Measured: 12 months
Secondary outcomes (1)
soft tissue changes
evaluation of Probing depth around implants by a graduated dental probe , differences in volume changes by Standard Triangle Language( STL) files superimposition of the arches digitally by etc: Medit software.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start21 Apr 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Teeth LossStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382337
- Sponsor's protocol ID
- A03010240S
- Status last verified
- Mar 2024
- First submitted
- 10 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sarnachiaro GO, Chu SJ, Sarnachiaro E, Gotta SL, Tarnow DP. Immediate Implant Placement into Extraction Sockets with Labial Plate Dehiscence Defects: A Clinical Case Series. Clin Implant Dent Relat Res. 2016 Aug;18(4):821-9. doi: 10.1111/cid.12347. Epub 2015 Apr 27.
PubMed 25916859undefined
Th Elaskary A, Gaweesh YY, El Tantawi M, Maebed MA. Vestibular Socket Therapy: A Novel Approach for Implant Placement in Defective Fresh Extraction Sockets With or Without Active Socket Infection (One-Arm Cohort Study). Int J Oral Maxillofac Implants. 2021 Jan-Feb;36(1):146-153. doi: 10.11607/jomi.8732.
PubMed 33600536Ghallab NA, Elaskary A, Elsabagh H, Toukhy AE, Abdelrahman H, El-Kimary G. A novel atraumatic extraction technique using vestibular socket therapy for immediate implant placement: a randomized controlled clinical trial. Oral Maxillofac Surg. 2023 Sep;27(3):497-505. doi: 10.1007/s10006-022-01089-4. Epub 2022 Jun 20.
PubMed 35718834Elaskary A, Meabed M, Abd-ElWahab Radi I. Vestibular socket therapy with immediate implant placement for managing compromised fresh extraction sockets: A prospective single-arm clinical study. Int J Oral Implantol (Berl). 2021 Aug 20;14(3):307-320.
PubMed 34415130
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maxillary Anterior Teeth Replacement With Immediate Dental Implants Utilizing Vestibular Socket Therapy Versus Ice Cream Cone Technique
- ClinicalTrials.gov ID
- NCT06382337
- Acronym / sponsor ID
- A03010240S
- Conditions
- Teeth Loss, Alveolar Bone Resorption
- Keywords
- VST, immediate dental implants, ice cream cone technique, Type 2 socket
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 21 Apr 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study will be to evaluate maxillary anterior teeth replacement with immediate dental implant utilizing vestibular socket therapy versus ice cream cone technique both clinically and radiographically.
Detailed description
Tooth loss is the endpoint of oral diseases, such as dental caries and periodontitis, and reflects the utilization of dental services during a lifetime .
The incidence of tooth loss has significantly declined at the global levels. However, tooth loss and oral diseases are still a major public health concern worldwide.
In the anterior region, the common reason for tooth loss is due to traumatic injury or congenital anomaly, loss of a single tooth may cause functional and esthetic deficits to the patient. Tooth extraction usually accompanies alveolar ridge resorption along with loss of preexisting tissue morphology.
There is a new developed a post-extraction fresh socket classification system as follows: Type 1: The facial soft tissue and buccal plate of bone are at normal levels in relation to the cement enamel junction of the pre-extracted tooth and remain intact post extraction.
Type 2: Facial soft tissue is present, but the buccal plate is partially missing following extraction of the tooth. Type 3: The facial soft tissue and the buccal plate of the bone are both markedly reduced after tooth extraction. This classification enabled ordering and classifying of post-extraction sockets.
A recently published sub-classification of type 2, now allows even greater clarity to plan regeneration: Type 2 A: Absence of the coronal one-third of labial bone plate of the extraction socket 5mm to 6mm from the free gingival margin. Type 2 B: Absence of the middle to coronal two thirds of the labial bone plate of the extraction socket approximately 7mm to 9mm from the free gingival margin.
Type 2 C: Absence of the apical one-third of the labial bone plate of the extraction socket 10 mm or more from the free gingival margin. For the management of socket defects after extraction numerous techniques have been developed to allow for optimum esthetic and functional outcomes. Among those techniques are ice cream cone technique described by Deniss Tarnow and the more recently introduce vestibular socket therapy (VST) introduced by Abd Salam Elaskary . Deniss Tarnow invented his technique (ice cream cone) to augment the socket with buccal dehiscence, in this technique, socket preservation was done using a collagen membrane shaped into an ice cream cone and placing it inside the extraction socket to cover the dehiscence site and the socket occlusally at the same time.
The regeneration of the buccal plate using the "ice cream cone" technique was possible in the dental extraction and by the immediate implant in an infected site in a case report of a 53 years old patient, and also in a clinical case series. But this technique is only recommended for simple dehiscence and not a wall defect. This technique is not applicable for a completely defective or missing bone wall unless a flap is raised, and (GBR) procedure is performed. Difficulty in placing the membrane as it become softened when exposed to fluid. In 2020 , Abd salam Elaskary , introduced vestibular socket therapy (VST), a novel minimally invasive surgical technique that allowed placement of immediate implant in maxillary class I and class II fresh extraction sockets with or without infective signs.
A 1-cm long vestibular access incision was made using a 15 blade 5-6 mm apical to the mucogingival junction of the socket, exposing the alveolar bone. The vestibular tissues were dissected in a coronal direction to detach the periosteum, forming a sub-periosteal tunnel connecting the vestibular incision to the socket orifice,bone graft was then introduced through the vestibular access incision to augment the labial plate of bone and fill any jumping gap. A flexible cortical membrane of 0.6 mm thickness was inserted and positioned 1 mm apical to the soft tissue margin and secured using two tacks apically. A customized healing abutment was fabricated to cover the implant and seal the socket .
This technique has many advantages : firstly, the nature of the vestibular extraction approach does not cause any trauma, pressure, or laceration to the soft tissue margin, which in turn has a positive impact on enhancing the mid-facial soft tissue levels, as the root was only pushed in an incisal direction through the created 6vestibular pouch, thus minimizing the osteoclastic activity around the socket rim .
, so it overcomes the remodeling sequelae of tooth extraction and to minimize the mid facial peri-implant gingival recession.
Secondly ,the use of a slowly resorbing flexible labial shield allowed for remodeling of the underlying labial bone plate while maintaining the socket dimensions and contours throughout the follow-up period. Thirdly, the membrane fixation, which is known to be pivotal for the GBR stability and regenerative outcomes. and finally connective tissue grafting can be done in type II sockets exhibiting a thin biotype. In these cases, the soft tissue graft counteracted the detrimental effect of the thin gingival phenotype on horizontal bone loss and midfacial mucosal recession.
VST can manage both type I and II socket defects, and could shorten the treatment time by up to two-thirds of that required for bone grafting and delayed implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A :immediate dental Implants cases with ice-cream cone technique in type 2 socket | Experimental | Other: Group A : ice cream cone techniqueimmediately placed implants in which the socket defect will be treated utilizing ice cream cone technique by Dennis Tarnow using collagen membrane , allograft bone graft and custom healing abutments |
| Group B : immediate dental Implants cases with the vestibular socket therapy in type 2 socket | Experimental | Other: Group B : the vestibular socket therapy8 immediately placed implants in which the socket defect will be treated utilizing vestibular socket therapy technique using cortical lamina , allograft , bone tacks for fixation and custom healing abutment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age more than 18 - 40 years.
- Patients with missing single tooth or teeth in the esthetic zone.
- Patients with buccal wall defect Type 2 A, B sockets (thin labial plate of bone less than 0.5 mm, presence of dehiscence or fenestration).
- Good oral hygiene.
- Patients willing to be present during the study follow-up intervals.
Key exclusion criteria (4 listed)
- Smoking people.
- Alcohol or drug abuse.
- Pregnancy.
- Patients with poor oral hygiene or progressive periodontal disease .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A : ice cream cone techniquecollagen membrane and allograft bone for labial plate augmentation simultaneously with immediate implants placements in maxillary anterior region in the defected type 2 socket , custom healing abutment for soft tissue preservation in ice cream cone group | Other | Group A :immediate dental Implants cases with ice-cream cone technique in type 2 socket |
| Group B : the vestibular socket therapycortical lamina fixed by bone tacks and allograft bone for labial plate augmentation simultaneously with immediate implants placements in maxillary anterior region in the defected type 2 socket , custom healing abutment for soft tissue preservation in ice cream cone group | Other | Group B : immediate dental Implants cases with the vestibular socket therapy in type 2 socket |
Primary outcome
Bone changes
Time frame: 12 months
bone changes in volume by cone-beam computed tomography (CBCT )radiographically .
1 secondary outcome
soft tissue changes
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Background: PubMed 25916859Sarnachiaro GO, Chu SJ, Sarnachiaro E, Gotta SL, Tarnow DP. Immediate Implant Placement into Extraction Sockets with Labial Plate Dehiscence Defects: A Clinical Case Series. Clin Implant Dent Relat Res. 2016 Aug;18(4):821-9. doi: 10.1111/cid.12347. Epub 2015 Apr 27.
- Backgroundundefined
- Background: PubMed 33600536Th Elaskary A, Gaweesh YY, El Tantawi M, Maebed MA. Vestibular Socket Therapy: A Novel Approach for Implant Placement in Defective Fresh Extraction Sockets With or Without Active Socket Infection (One-Arm Cohort Study). Int J Oral Maxillofac Implants. 2021 Jan-Feb;36(1):146-153. doi: 10.11607/jomi.8732.
- Background: PubMed 35718834Ghallab NA, Elaskary A, Elsabagh H, Toukhy AE, Abdelrahman H, El-Kimary G. A novel atraumatic extraction technique using vestibular socket therapy for immediate implant placement: a randomized controlled clinical trial. Oral Maxillofac Surg. 2023 Sep;27(3):497-505. doi: 10.1007/s10006-022-01089-4. Epub 2022 Jun 20.
- Background: PubMed 34415130Elaskary A, Meabed M, Abd-ElWahab Radi I. Vestibular socket therapy with immediate implant placement for managing compromised fresh extraction sockets: A prospective single-arm clinical study. Int J Oral Implantol (Berl). 2021 Aug 20;14(3):307-320.
- An Ice cream cone technique. PaperLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A : ice cream cone technique and Group B : the vestibular socket therapy in people with Teeth Loss and Alveolar Bone Resorption, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Shoeib (+20 1091950453, mohamedfaisal651@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone changes (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06382337, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.